A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013)

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The purpose of this trial is to evaluate the safety, tolerability, and efficacy of pembrolizumab (MK-3475, KEYTRUDA®) in hematologic malignancies. The primary study hypotheses are that treatment with pembrolizumab will result in a clinically meaningful improvement in Objective Response Rate (ORR) or Complete Remission Rate (CRR).

With Protocol Amendment 08, enrollment in the Multiple Myeloma arm (Cohort 2) has been completed and no further enrollment will be allowed and enrollment in the Non-Hodgkin Lymphoma Diffuse Large B Cell Lymphoma arm (Cohort 5) has been discontinued and no further enrollment will be allowed.

(Completed) 10 mg/kg by intravenous (IV) infusion every 2 weeks (Q2W). Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable adverse event(s) (AEs), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after Complete Response (CR) if treatment has been administered for 24 weeks and 2 doses have been administered after CR.

(Completed) Participants receive pembrolizumab 200 mg by IV infusion every 3 weeks (Q3W). Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after stringent complete response (sCR) if treatment has been administered for 24 weeks and 2 doses have been administered after sCR.

(Completed) 10 mg/kg by IV infusion Q2W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.

Participants receive pembrolizumab 200 mg by IV infusion every 3 weeks (Q3W). Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.

Biological: Pembrolizumab

IV infusion

Other Names:

MK-3475

KEYTRUDA®

Experimental: Cohort 4B: R/R PD-L1-positive NHL

(Completed) Participants receive pembrolizumab 10 mg/kg by IV infusion Q2W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.

Biological: Pembrolizumab

IV infusion

Other Names:

MK-3475

KEYTRUDA®

Experimental: Cohort 4C: Relapsed/refractory Follicular Lymphoma (FL)

Participants receive pembrolizumab 200 mg by IV infusion Q3W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.

Biological: Pembrolizumab

IV infusion

Other Names:

MK-3475

KEYTRUDA®

Experimental: Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Participants receive pembrolizumab 200 mg by IV infusion Q3W. Treatment with pembrolizumab will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and 2 doses have been administered after CR.

Biological: Pembrolizumab

IV infusion

Other Names:

MK-3475

KEYTRUDA®

Experimental: Cohort 5: R/R DLBCL combination treatment

(Discontinued) Participants receive pembrolizumab 200 mg by IV infusion Q3W + lenalidomide 25 mg capsule by mouth (PO) or recommended Phase II dose for 21 consecutive days with 7 days off. Treatment with pembrolizumab + lenalidomide will continue for up to 2 years or until documented disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, participant withdraws consent, pregnancy of the participant, noncompliance with trial treatment or procedure requirements, or administrative reasons. Can stop after CR if treatment has been administered for 24 weeks and they receive an additional 21 consecutive daily doses of lenalidomide + 2 doses of pembrolizumab after CR.

Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 30 days after end of treatment for non-serious events and 90 days after end of treatment for serious events (up to 27 months) ]

Number of Participants Discontinuing Treatment due to an AE [ Time Frame: Up to end of treatment (up to 2 years) ]

Cohort 1: Objective Response Rate (ORR) Based on International Working Group (IWG) Criteria for MDS [ Time Frame: Up to end of treatment (up to 2 years) ]

Cohort 2: ORR based on International Myeloma Working Group (IMWG) criteria [ Time Frame: Up to end of treatment (up to 2 years) ]

Cohort 3: Complete Remission Rate (CRR) Based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to end of treatment (up to 2 years) ]

Cohort 4: ORR Based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to end of treatment (up to 2 years) ]

Cohort 5: ORR Based on Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to end of treatment (up to 2 years) ]

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Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale

Demonstrates adequate organ function

Prior therapy criteria must be met

Exclusion Criteria:

Is currently participating in and receiving study therapy or has participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of study therapy

Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years, has received a live vaccine within 30 days of planned start of study therapy, has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1, received a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered from adverse events due to a previously administered agent

Has known clinically active central nervous system (CNS) involvement

Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis